Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06206512 |
| Other study ID # |
SAR065-124 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Sarfez Pharmaceuticals, Inc. |
| Contact |
Salim Shah, PhD |
| Phone |
877-872-7339 |
| Email |
clinicaltrials[@]sarfez.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research study is being done to compare the effectiveness two drugs: an extended release
torsemide (ERT) versus generic immediate release Torsemide (IRT) in reducing the worsening of
symptoms of Overactive Bladder (OAB i.e., frequency, urgency, or urgency incontinence) in
patients with chronic congestive heart failure (CHF).
This study will include CHF patients who experience worsening OAB) symptoms with use of a
loop diuretic. The total duration of the study is about eight weeks with a total of nine
visits.
There will be a screening visit that lasts one to two hours. The screening visit includes
history and physical exams, blood draws, and urine analysis. If eligible for the study,
participants will receive either generic torsemide or extended release torsemide for the
first four weeks. Participants will do a virtual research visit on week one, two and three to
submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks,
history and physician exam will be done and blood will be collected. Participants will be
assigned to receive either extended release torsemide (if they initially received generic
torsemide) and generic torsemide (if they initially received extended release torsemide) for
the next four weeks. Participants will attend virtual research visits on week five, six and
seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end
of the study in week eight, they will have history and physical exams and blood draws.
Some risks from the study may include side effects of torsemide like acute kidney injury,
fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.
Description:
This study has been designed to evaluate the efficacy of 24mg/48mg once daily dose of
Investigational Product [Extended release torsemide of Sarfez Pharmaceuticals Inc.] to
20mg/40mg once daily dose of generic immediate release torsemide in reducing the symptoms of
overactive bladder (OAB) in Chronic Heart Failure (CHF) patients.
Study Rationale Majority of chronic heart failure (CHF) patients are aged ≥50 and have
symptoms of overactive bladder such as micturition frequency and urgency with or without
urgency incontinence on stable dose of loop diuretics. Studies have shown that at normal
physiological filling rate, intravesicular pressure does not rise until bladder capacity is
reached. However, when the filling rate is higher than the normal physiological rate, the
intravesicular pressure rises before bladder capacity is reached. Since loop diuretic
increase filling rate, they are likely to raise intravesicular pressure much before it
reaches capacity, and hence increase urgency. Therefore, there is a need for loop diuretic
with a more gradual filling rate to alleviate loop diuretic induced exacerbation of symptoms
OAB such as urgency and frequency. The proposed study follows upon successful clinical trial
where in healthy volunteers, extended release torsemide of Sarfez Pharmaceutical Inc.
decreased peak urine volume by >30% and induced gradual diuresis, indicating a gradual
bladder filling. Therefore, this study is designed to determine if extended release torsemide
of Sarfez Pharmaceutical Inc. can improve the bladder symptoms in heart failure patients as
compared to a generic torsemide.
Patients who meet all inclusion and exclusion criteria, after obtaining written informed
consent, will be screened using a four-question bladder condition assessment tool (score 0-5)
and, only patients who score ≥4 score on each of the questions (total score ≥16) and meeting
all other eligibility criteria will be enrolled in the study. The trial period will be
divided into two periods as described above and shown in study flow schema (Figure 1). The
total duration of the study would be 56 days excluding the day of enrolment in the study.
Patients will visit the Clinical Research Unit/hospital at following schedules.
Visit 1: (Screening and Enrollment) start of study: After confirmation of eligibility and
screening, patients will be randomized, HRQL tool and BS tool will be administered,
(Baseline) and medications will be dispensed. Blood will be collected for NT-pro-BNP test and
basic metabolic panel and body weight will also be measured. 6MWT will be performed. The
other assessments will be done as mentioned in the study assessment schedule. Pregnancy test
will be done to rule out pregnancy.
Period 1: All the enrolled patients who were on stable daily dose of furosemide will be
randomized to either ERT or generic IRT. Patients who were on stable daily dose of furosemide
40 mg will be randomized to either ERT 24 mg or generic IRT 20 mg. Similarly, patients who
were on stable daily dose of furosemide 80 mg will be randomized to either ERT 48 mg (two 24
mg tablets) or generic IRT 40 mg (two 20mg tablets). All pre-screening treatments will be
recorded, and other concomitant medications will be continued (except non-steroidal
anti-inflammatory agents but aspirin (<100 mg per day) will be permitted, cyclooxygenase-2
inhibitors such as Celecoxib, and allopurinol). On the same day HRQL tool and BS tool will be
administered (Baseline assessments). Trained study coordinator will do a virtual visit on the
last day of week 1, 2, and week 3 to provide and collect daily diary and to administer BS
tool in week 2 and week 3. Upon diary collection, the study coordinator will check the diary
for completion, and, if the diary is not properly completed, the study coordinator
re-educates or re-instructs the patient with proper diary data filling procedures. Any
retrospective modification or notation in the diary is strictly prohibited.
End of Period 1 and Cross Over: At the end of Week 4 (Day 28) patients will visit the site.
After collecting daily diary from Period 1, the following assessment tools will be
administered: HRQL tool, BS tool, and PGI-C questionnaires for frequency, urgency,
urgency-incontinence, overall bladder problems, daily life and treatment satisfaction
(anchors). Blood sample will be collected for basic metabolic panel and NT-proBNP and body
weight will be measured. 6MWT will be performed along with physical examination and vital
signs assessments.
On the same day medications will be switched and drug will be dispensed. Other assessments
will be done as per the study assessment schedule.
Period 2: Trained study coordinator will do a virtual visit on the last day of week 5, week
6, and week 7 to provide daily diary and to collect the previous week's diary as well as to
administer BS tool in week 6 and week 7. Upon diary collection, study coordinator will check
the diary for completion, and, if the diary is not properly completed, the study coordinator
will re-educate or re-instruct the patient with proper diary data filling procedures. Any
retrospective modification or notation in the diary is strictly prohibited.
End of Study: At the end of Period 2 (Week 8, Day 56), following instruments will be
administered along with the collection of weeks 8 diary: HRQL tool, BS tool, and PGI-C
questionnaires for frequency, urgency, urgency-incontinence, overall bladder problems, daily
life and treatment satisfaction (anchors). On the same day end of study assessment will be
done as per the study assessment schedule and blood will be collected for basic metabolic
panel and NT-pro-BNP. Also, body weight will be measured. 6MWT will be performed. End of
study assessments will be performed as per study assessment schedule. Assessment Windows The
deviations for the assessment times are acceptable based on logistical and operational
considerations.
